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U.S. Department of Health and Human Services

Food

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Environmental Decision Memo for Food Contact Notification No. 001086

Date:April 4, 2011
From:Biologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 1086 – Ethylene/propylene copolymers as the basic polymers in the production of single- and repeat-use articles intended to contact food.
Notifier:PPG Industries, IncLyondellBasell Industries
3801 West Chester Pike
Newtown Square, PA 19073
To:Division of Food Contact Notifications (HFS-275)
Attention: Helen Hc C Lee, Ph.D.
Through: Annette McCarthy, Ph.D., Senior Science and Policy Staff

For requested repeat-use applications, we have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section, 21 CFR 25.32 (j), under which the categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

For remaining requested uses, attached is the Finding of No Significant Impact (FONSI) for FCN 1086. After this notification becomes effective, copies of the FONSI, and the notifier's environmental assessment, dated March 9, 2011, may be made available to the public. We shall post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

Please let us know if there is any change in the identity or use of the food contact substance.

 

Leah D. Proffitt

 

Attachments:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 1086), submitted by LyondellBasell Industries, to provide for the safe use of ethylene/propylene copolymers as the basic polymer in the production of single- and repeat-use articles intended to contact food.

The Environmental Review Team has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and, therefore, will not require the preparation of an environmental impact statement. This finding is based on information, submitted by the notifier, in an environmental assessment, dated March 9, 2011, and other information known to the agency.

 

Prepared by __________________________________________Date: April 4, 2011
Leah D. Proffitt
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: April 4, 2011
Annette McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration